Without automated eTMS tools (an enterprise tool management system), managing a clinical trial efficiently poses a number of challenges.
For example, setting up a study can be a major lift when previous documents and workflows aren’t analyzed for effectiveness or carried over. Similarly document management in traditional paper-based trial master file (TMF) systems is onerous and clunky, and setting and tracking key performance indicators (KPIs) is challenging when data isn’t standardized or centralized.
Today, clinical trial management systems overcome many of the traditional technical challenges of running a clinical trial. Automated eTMS tools like Anju Software’s CTMS Master allow clinical trial teams to work more efficiently, capture data more thoroughly, and meet compliance demands more readily.
Technical Challenges of Managing Clinical Trials
Today’s top technical challenges in managing clinical trials include:
- Lack of standardized forms and processes for launching a clinical trial, resulting in teams feeling as if they’re reinventing the wheel with each new study.
- Outdated document management, often through the use of a paper trial master file.
- Wasted time and increased errors associated with manual data entry — even when it consists of entering the same basic information again and again.
- Difficulties analyzing data for insights into financial management, time use, and other key aspects of running an efficient clinical trial.
- Problems keeping up with increasingly complex and stringent compliance and auditing demands.
In the life sciences field, the transition from paper-based to fully electronic systems remains a work in progress. Many clinical trial teams continue to embrace paper because they are accustomed to it, but it poses many limitations, writes Mae Losasso at NS Healthcare.
Digital tools can address a number of these problems, Ilhaam A. Omar and fellow researchers write in the Arabian Journal for Science and Engineering. Yet challenges remain in incorporating the latest technologies, such as blockchains, into the healthcare field.
Today, the most reliable automated eTMS tools are comprehensive, integrated clinical trial management platforms.
Using Automated eTMS Tools to Resolve Technical Challenges
Automated trial master file systems allow clinical trial teams to overcome a number of technical challenges. Anju Software’s CTMS Master offers one example of a clinical trial management system designed to confront and address common technical challenges.
Efficient, Standardized Study Set-Up
CTMS Master allows clinical trial teams to create standard templates for project and site documents, reports, correspondence, and more.
These standardized documents make it easier to collect, locate, and review information, allowing study teams to launch a clinical trial more efficiently. They also improve efforts to collect meaningful consent documentation from patients — an essential first step, Giuseppe Albanese and fellow researchers note in the Journal of Ambient Intelligence and Humanized Computing.
Improved Document Management
CTMS Master uses an electronic trial master file (eTMF) system to manage documents electronically while also boosting security. Role-based access controls allow system administrators to assign access to documents by role. These controls also make it easy to tell which users opened, edited, or moved which documents.
Integrated Monitoring Tools and Automated Data Sharing
CTMS Master’s integrated Site Visit Report tool automatically imports relevant data. This feature eliminates time wasted on duplicate data entry. It also reduces the risk that repeated, redundant data-entry tasks will introduce errors into clinical trial documentation.
Better Project Insight Through Advanced Report Generation
Need to see key metrics and statistics at a glance? CTMS Master tracks more than 100 separate data points related to projects, countries, and clinical trial sites.
The system offers over 200 standard report templates for easy data visualization and analysis. Reports can also be customized as needed.
Robust Finance Management and Auditing Capabilities
Manage all your budget information in one place. CTMS Master allows clinical trial teams to define site-specific budgets, track payments and receipts, set role-based access for financial data, and easily create invoices as needed.
Clinical trials pose a number of technical challenges. With a comprehensive clinical trial management system, clinical trial teams can prevent, overcome, or mitigate these challenges to conduct clinical trials more efficiently and effectively.
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